The LILY clinical study is for people who have celiac disease. The study will explore whether the study medication is safe for adults as a potential celiac disease treatment.
Study participants may be able to join the study if they meet the following requirements:
- You are 18-65 years old
- You have celiac disease
- You are already on a gluten-free diet
- You have had a diagnostic biopsy
Other requirements will apply.
See if You May QualifyDepending on whether you join Part A or Part B, your participation in the LILY study will last either 7 or 9 months and will consist of the following parts:
- Screening and Randomization (up to 1 month)
- To see if you qualify, you will visit the study clinic and receive health assessments, such as a physical exam, blood tests, and cognitive tests.
- If you qualify, you will be randomly assigned to receive either the study medication or placebo (no active ingredients). You have a 3 in 4 chance of receiving the study medication.
- Part A (up to 6 months)
- You will have 1 dose of the study medication and visit the study clinic at least 6 times. On your first visit, you will stay overnight at the study clinic for 3 nights in a row to ensure your safety.
- Your total participation in this study will last approximately 25 weeks and up to 16 study visits to the study site.
- Part B (up to 8 months)
- You will have 7 doses of the study medication and visit the study clinic at least 12 times.
- Your total participation in this study will last approximately 35 weeks and up to 23 study visits to the study site. Some follow-up visits may occur remotely. Your study doctor will provide more information if applicable.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
